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FDA 510(k)

GENESIS

K-Number: K081559 · 2008-08-28

ApplicantMedisiss
Decision Date2008-08-28
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENESIS is the device name listed in this FDA 510(k) record. The listed applicant is Medisiss. It received FDA 510(k) clearance on 2008-08-28 under 510(k) number K081559. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS?

GENESIS is a medical device that received FDA 510(k) clearance on 2008-08-28. The listed applicant is Medisiss. The 510(k) number is K081559.

When did GENESIS receive FDA 510(k) clearance?

GENESIS received FDA 510(k) clearance on 2008-08-28, under 510(k) number K081559.

Who is the listed applicant for GENESIS?

The FDA 510(k) record lists Medisiss as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENESIS?

The FDA product code for GENESIS is GEI.

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Other records listing Medisiss as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K113028MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURSK100543MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01K042659MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPSK030598MEDISISS REPROCESSED ULTRASONIC SURGICAL INSTRUMENTSK030919SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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